NTG · Prosthesis, Ankle, Uncemented, Non-Constrained
· Class 3
Overview
| Product Code | NTG |
|---|---|
| Device Name | Prosthesis, Ankle, Uncemented, Non-Constrained |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P160036 | Hintermann Series H3 Total Ankle Replacement System | Dt Medtech, LLC | Jun 4, 2019 | APPR |
| P050050 | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) | Djo Global | May 27, 2009 | APPR |
Top Applicants
- Djo Global — 1 clearance
- Dt Medtech, LLC — 1 clearance
